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Efficacy of Nerve Block Versus Botox in Chronic Migraine Management

NCT06684249 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2024-11-12

No results posted yet for this study

Summary

The goal of this clinical trial is to determine whether nerve block injections (specifically, supratrochlear and greater occipital nerve injections) are as effective as Botulinum toxin A (Botox) injections in treating chronic migraine in adults.

The main questions it aims to answer are:

* Do nerve block injections reduce the number of monthly migraine days compared to baseline?
* Are there any differences in the frequency of migraine-related symptoms between the nerve block and Botox treatment groups?
* Which treatment leads to higher patient satisfaction and improved quality of life?

Participants in this study will:

* Receive either nerve block injections or Botox injections every 12 weeks.
* Visit the clinic once every month for follow-ups and assessments.
* Maintain a headache diary to record the frequency and severity of their migraines and any adverse effects experienced.
* Researchers will compare the outcomes of the two groups to determine if one treatment is superior in terms of efficacy and patient satisfaction.

Conditions

  • Chronic Migraine
  • Chronic Migraine, Headache

Interventions

PROCEDURE

Nerve Block Injections

This intervention involves the administration of supratrochlear and greater occipital nerve block injections. The injections consist of a mixture of local anesthetics and corticosteroids, designed to reduce the frequency and severity of migraine episodes. The procedure will be repeated every 12 weeks for a total duration of 6 months to assess the long-term efficacy and safety in managing chronic migraine.

DRUG

Botulinum Toxin A

Participants in this arm will receive Botulinum toxin A injections as per the PREEMPT protocol tailored for chronic migraine treatment. The treatment involves multiple injections around the head and neck regions, administered every 12 weeks over a 6-month period. This standard approach aims to reduce migraine frequency through neuromodulation of pain pathways.

Sponsors & Collaborators

  • Zagazig University

    lead OTHER_GOV

Principal Investigators

  • Ahmed Bessar, MD, PhD · Assistant Professor of Diagnostic and Interventional Radiology, Zagazig Uni.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-10
Primary Completion
2025-05-10
Completion
2025-07-10

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06684249 on ClinicalTrials.gov